The Effects of Tranexamic Acid on Blood Loss During Orthognathic Surgery
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- blood loss during surgery
研究概览
简要总结
This study seeks to answer the question: Does a single pre-operative dose of tranexamic acid have a statistically significant reduction in blood loss during orthognathic surgery?
If it does, this drug may begin to be used routinely during orthognathic surgery to reduce blood loss in our patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The patient will be unaware of which group they have been randomized into
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing either
- •Bilateral saggital split osteotomy (lower jaw surgery)
- •Lefort 1 osteotomy (upper jaw surgery)
- •Combination of BSSO and Lefort
- •Patients between with ages of 16-65
- •No cardiac comorbidities (hypertension, congenital heart malformation)
- •No known coagulopathy
- •No regular prescription medication altering normal blood coagulation (NSAIDs, other anticoagulants)
- •ASA I and II patients
排除标准
- •Patients younger than 16 and older than 40
- •Patients with known coagulopathy
- •Patients with cardiac comorbidities
- •Patients with a family history of bleeding disorders
- •Patients who have undergone previous orthognathic surgery
- •ASA III patients or higher
研究组 & 干预措施
Intervention TXA
patients receiving TXA10mg/kg IV pre-operatively
干预措施: Tranexamic Acid Injectable Solution (Drug)
Placebo
patients will receive an equivalent amount of normal saline 0.9% IV pre-operatively
干预措施: Placebo (normal saline 0.9%) (Other)
结局指标
主要结局
blood loss during surgery
时间窗: intra-operative only
meticulous measurement of the total blood loss encountered during surgery
次要结局
未报告次要终点
研究者
Nick Emanuele
Resident, Oral and Maxillofacial Surgery
Nova Scotia Health Authority